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Nerlynx

(Neratinib Oral Tablet)

PPuma Biotechnology, Inc.

0

Indications

1

Total Trials

1

Active Trials

0

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Timeline

Expected Milestones

Q4 2027

Phase 1Recruiting

Metastatic Triple-Negative Breast Carcinoma

NCT06008275

Clinical

Trials by Indication[1]

Metastatic Triple-Negative Breast Carcinoma1 trial

Pilot Clinical Trial Examining the Safety and Efficacy of Neratinib in Combination With Ruxolitinib in Patients With Chemotherapy-pretreated Metastatic Triple Negative Breast Cancer With Chest Wall Recurrence

Recruiting·BBaylor Research Institute·Phase 1·NCT06008275·20 enrolled

Regulatory

FDA Approval Timeline[3]

Jul 17, 2017

NERLYNX

NDA NDA208051

Sources

References

[1]
ClinicalTrials.gov — 1 trial record for Neratinib Oral Tablet. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Neratinib Oral Tablet compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA208051). U.S. Food & Drug Administration.
[4]
SEC EDGAR — Puma Biotechnology, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Company: PPuma Biotechnology, Inc.

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